PulpitisNCT02940782
Comparison Between Reciproc and Oneshape Systems
A study testing Reciproc single file system, One Shape single file system and X-smart Plus, Dentsply Maillefer, Ballaigues, Switzerland in people with Pulpitis, run by Cairo University.
Trial summary
A randomized clinical trial to assess postoperative pain in patients with symptomatic irreversible pulpitis after using Reciproc versus One Shape rotary NiTi Systems. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Pulpitis
- What is being tested?
- Reciproc single file system, One Shape single file system and X-smart Plus, Dentsply Maillefer, Ballaigues, Switzerland
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mandibular premolar teeth with:
- Single canal
- Preoperative sharp pain.
- Vital response of pulp tissue.
- Normal periapical radiographic appearance or slight widening in lamina dura.
- Final diagnosis for an eligible patient will take place by radiograph and pulp testing.
Who cannot join
- Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment.
- Patients who have more than one tooth in the same quadrant and/or opposite quadrant that require an endodontic treatment.
- Pregnant females.
- Patients having significant systemic disorder.
- If antibiotics have been administrated during the past two weeks preoperatively.
- Patients having bruxism or clenching.
Show all 11Show fewer
- Teeth that have:
- Non-vital pulp tissues.
- Association with swelling or fistulous tract.
- A pocket depth greater than 5 mm.
- Previous endodontic treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Postoperative Pain After Using Reciroc Versus One Shape NiTi Systems in Patients With Symptomatic Irreversible Pulpitis (A Randomized Clinical Trial): Part Two
A randomized clinical trial to assess postoperative pain in patients with symptomatic irreversible pulpitis after using Reciproc versus One Shape rotary NiTi Systems.
Read the detailed description
The study aims at comparing postoperative pain after using two single-file NiTi systems, Reciproc reciprocating system and One Shape rotary system, for root canal instrumentation in patients with symptomatic irreversible pulpitis.
After the patient is found eligible, he/she will be randomly assigned to either the control (One Shape) or experimental group (Reciproc) and will be treated in a single visit.
Sequence of Procedural Steps:
- Assessment of preoperative pain by NRS before administration of anesthesia.
- Administration of local anesthesia using 2% lidocaine (1:100,000 adrenaline).
- An access cavity will be done using a round bur and Endo-Z bur.
- Isolation of the affected tooth with rubber dam.
- Determination of the working length using an electronic apex locator, and confirmed by a radiograph using K-file. Then, the working length will be established at 0.5 mm up to the radiographic apex.
- Canals will be explored with hand K-file ISO sizes 10, 15, 20.
- Mechanical preparation for both groups will be as follows:
- Experimental group:
- Canals will be instrumented using Reciproc reciprocating system set on an electric motor, with adjusted torque and speed according to the manufacturer's instructions.
- There is no need for coronal preflaring with a Gates Glidden drill or an orifice opener since the design of the Reciproc instrument allows any obstructions in the coronal third to be removed, as claimed by the manufacturer.
- Reciproc file selection: R40 (40/0.06)
- Control group:
- Coronal preflaring will be performed using Gates Glidden drill.
- Canals will be instrumented using One Shape single-file (25/0.06) set on an electric motor with adjusted torque and speed according to the manufacturer's instructions.
- For wide canals, One Shape Apical (30/0.06, 37/0.06) will be used.
- The rotary files will be introduced inside the canal using EDTA gel.
- Canals will be irrigated with 2.6% sodium hypochlorite solution between every subsequent instrument. It is prepared by adding 10 ml of sterile distilled water to 10 ml of 5.25% sodium hypochlorite solution using a 27 gauge needle fit to 5ml disposable plastic syringe placed in the canal space without binding.
- Canals will be dried with sterile paper points and obturated using lateral condensation technique. A spreader will be used to allow space for auxiliary cones, with resin-based root canal sealer.
- The tooth will be sealed by temporary restoration, and postoperative pain will be assessed immediately after the end of treatment.
- The patient will be phone called for follow up after 6, 12, 24, 48 and 72 hours.
- The patient will be instructed to return to complete the treatment procedures until placing a full-coverage restoration.
- The patient will be instructed to take one tablet 600 mg Ibuprofen if he/she experiences severe pain.
- Conditions
- Pulpitis
- Being tested
- Reciproc single file system, One Shape single file system, X-smart Plus, Dentsply Maillefer, Ballaigues, Switzerland
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reciproc single file systemProcedure or surgery
A reciprocating Nickel Titanium single file system used for instrumentation of root canals in endodontic treatment.
One Shape single file systemProcedure or surgery
A rotary Nickel Titanium single file system used for instrumentation of root canals in endodontic treatment.
X-smart Plus, Dentsply Maillefer, Ballaigues, SwitzerlandDevice
It is a micro-motor designed for performing root canal treatments with the reciprocating, single file technique or traditional continuous rotation file system.
| Study group | Role | What they receive |
|---|---|---|
| Reciproc single file system | Experimental | It is a reciprocating NiTi file used for instrumentation of root canals in endodontic treatment Receives: Procedure: Reciproc single file system; Device: X-smart Plus, Dentsply Maillefer, Ballaigues, Switzerland |
| One Shape single file system | Active comparator | It is a rotary NiTi file used for instrumentation of root canals in endodontic treatment Receives: Procedure: One Shape single file system; Device: X-smart Plus, Dentsply Maillefer, Ballaigues, Switzerland |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the change in postoperative pain measured by the Numerical Rating Scale (0-10)
Pain intensity after root canal treatment will be measured using Numerical Rating Scale (0-10)
Measured: Immediately after treatment, then 6 hours, 12 hours, 24 hours and 72 hours after treatment.
Secondary outcomes (1)
Number of analgesics taken by the patient
It will be recorded by the patient with time intervals
Measured: 72 hours from the end of the endodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PulpitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Adel Abdullah Ali Soliman, Cairo University
- Investigators
- Ahmed A Soliman, B.D.S, Principal investigator, Faculty of Oral and Dental Medicine, Cairo UniversityAngie G Ghoneim, Study director, Faculty of Oral and Dental Medicine, Cairo UniversityShaimaa I Gawdat, Study chair, Faculty of Oral and Dental Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940782
- Sponsor's protocol ID
- reciproc_oneshape
- Status last verified
- Oct 2016
- First submitted
- 19 Oct 2016
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Neelakantan P, Sharma S. Pain after single-visit root canal treatment with two single-file systems based on different kinematics--a prospective randomized multicenter clinical study. Clin Oral Investig. 2015 Dec;19(9):2211-7. doi: 10.1007/s00784-015-1448-x. Epub 2015 Mar 15.
PubMed 25773449Kherlakian D, Cunha RS, Ehrhardt IC, Zuolo ML, Kishen A, da Silveira Bueno CE. Comparison of the Incidence of Postoperative Pain after Using 2 Reciprocating Systems and a Continuous Rotary System: A Prospective Randomized Clinical Trial. J Endod. 2016 Feb;42(2):171-6. doi: 10.1016/j.joen.2015.10.011. Epub 2015 Nov 29.
PubMed 26614017
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Pain After Using Reciroc Versus One Shape NiTi Systems in Patients With Symptomatic Irreversible Pulpitis (A Randomized Clinical Trial): Part Two
- ClinicalTrials.gov ID
- NCT02940782
- Acronym / sponsor ID
- reciproc_oneshape
- Conditions
- Pulpitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized clinical trial to assess postoperative pain in patients with symptomatic irreversible pulpitis after using Reciproc versus One Shape rotary NiTi Systems.
Detailed description
The study aims at comparing postoperative pain after using two single-file NiTi systems, Reciproc reciprocating system and One Shape rotary system, for root canal instrumentation in patients with symptomatic irreversible pulpitis.
After the patient is found eligible, he/she will be randomly assigned to either the control (One Shape) or experimental group (Reciproc) and will be treated in a single visit.
Sequence of Procedural Steps:
- Assessment of preoperative pain by NRS before administration of anesthesia.
- Administration of local anesthesia using 2% lidocaine (1:100,000 adrenaline).
- An access cavity will be done using a round bur and Endo-Z bur.
- Isolation of the affected tooth with rubber dam.
- Determination of the working length using an electronic apex locator, and confirmed by a radiograph using K-file. Then, the working length will be established at 0.5 mm up to the radiographic apex.
- Canals will be explored with hand K-file ISO sizes 10, 15, 20.
- Mechanical preparation for both groups will be as follows:
- Experimental group:
- Canals will be instrumented using Reciproc reciprocating system set on an electric motor, with adjusted torque and speed according to the manufacturer's instructions.
- There is no need for coronal preflaring with a Gates Glidden drill or an orifice opener since the design of the Reciproc instrument allows any obstructions in the coronal third to be removed, as claimed by the manufacturer.
- Reciproc file selection: R40 (40/0.06)
- Control group:
- Coronal preflaring will be performed using Gates Glidden drill.
- Canals will be instrumented using One Shape single-file (25/0.06) set on an electric motor with adjusted torque and speed according to the manufacturer's instructions.
- For wide canals, One Shape Apical (30/0.06, 37/0.06) will be used.
- The rotary files will be introduced inside the canal using EDTA gel.
- Canals will be irrigated with 2.6% sodium hypochlorite solution between every subsequent instrument. It is prepared by adding 10 ml of sterile distilled water to 10 ml of 5.25% sodium hypochlorite solution using a 27 gauge needle fit to 5ml disposable plastic syringe placed in the canal space without binding.
- Canals will be dried with sterile paper points and obturated using lateral condensation technique. A spreader will be used to allow space for auxiliary cones, with resin-based root canal sealer.
- The tooth will be sealed by temporary restoration, and postoperative pain will be assessed immediately after the end of treatment.
- The patient will be phone called for follow up after 6, 12, 24, 48 and 72 hours.
- The patient will be instructed to return to complete the treatment procedures until placing a full-coverage restoration.
- The patient will be instructed to take one tablet 600 mg Ibuprofen if he/she experiences severe pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reciproc single file system | Experimental | Procedure: Reciproc single file system, Device: X-smart Plus, Dentsply Maillefer, Ballaigues, SwitzerlandIt is a reciprocating NiTi file used for instrumentation of root canals in endodontic treatment |
| One Shape single file system | Active comparator | Procedure: One Shape single file system, Device: X-smart Plus, Dentsply Maillefer, Ballaigues, SwitzerlandIt is a rotary NiTi file used for instrumentation of root canals in endodontic treatment |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Mandibular premolar teeth with:
- Final diagnosis for an eligible patient will take place by radiograph and pulp testing.
Key exclusion criteria (11 listed)
- Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment.
- Patients who have more than one tooth in the same quadrant and/or opposite quadrant that require an endodontic treatment.
- Pregnant females.
- Patients having significant systemic disorder.
- If antibiotics have been administrated during the past two weeks preoperatively.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reciproc single file systemA reciprocating Nickel Titanium single file system used for instrumentation of root canals in endodontic treatment. | Procedure or surgery | Reciproc single file system |
| One Shape single file systemA rotary Nickel Titanium single file system used for instrumentation of root canals in endodontic treatment. | Procedure or surgery | One Shape single file system |
| X-smart Plus, Dentsply Maillefer, Ballaigues, SwitzerlandIt is a micro-motor designed for performing root canal treatments with the reciprocating, single file technique or traditional continuous rotation file system. | Device | One Shape single file system, Reciproc single file system |
Primary outcome
Assessment of the change in postoperative pain measured by the Numerical Rating Scale (0-10)
Time frame: Immediately after treatment, then 6 hours, 12 hours, 24 hours and 72 hours after treatment.
Pain intensity after root canal treatment will be measured using Numerical Rating Scale (0-10)
1 secondary outcome
Number of analgesics taken by the patient
Time frame: 72 hours from the end of the endodontic treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Background: PubMed 25773449Neelakantan P, Sharma S. Pain after single-visit root canal treatment with two single-file systems based on different kinematics--a prospective randomized multicenter clinical study. Clin Oral Investig. 2015 Dec;19(9):2211-7. doi: 10.1007/s00784-015-1448-x. Epub 2015 Mar 15.
- Background: PubMed 26614017Kherlakian D, Cunha RS, Ehrhardt IC, Zuolo ML, Kishen A, da Silveira Bueno CE. Comparison of the Incidence of Postoperative Pain after Using 2 Reciprocating Systems and a Continuous Rotary System: A Prospective Randomized Clinical Trial. J Endod. 2016 Feb;42(2):171-6. doi: 10.1016/j.joen.2015.10.011. Epub 2015 Nov 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed A Soliman, B.D.S principal investigator
Faculty of Oral and Dental Medicine, Cairo University
Angie G Ghoneim study director
Faculty of Oral and Dental Medicine, Cairo University
Shaimaa I Gawdat study chair
Faculty of Oral and Dental Medicine, Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Reciproc single file system, One Shape single file system and X-smart Plus, Dentsply Maillefer, Ballaigues, Switzerland in people with Pulpitis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Soliman, B.D.S (+20-01003564036, aasoliman89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the change in postoperative pain measured by the Numerical Rating Scale (0-10) (time frame: Immediately after treatment, then 6 hours, 12 hours, 24 hours and 72 hours after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02940782, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016.